The advent of 5G technology marks a new era of connectivity, delivering unprecedented speed, low latency, and the ability to connect billions of devices seamlessly. This revolution is reshaping industries such as healthcare, transportation, smart cities and entertainment. However, these advancements also bring heightened security challenges. This complexity and expanded attack surface of 5G networks introduce risks and vulnerabilities that surpass those of previous mobile network generations.
Critical performance enhancements in 5G networks – enabled by softwarization, cloudification, and virtualization of network functions- have redefined wireless communication from access to core networks. Yet, these advancements expose networks to significant security risks. As This shift towards software-centric functions demands rigorous pre-deployment scrutiny of software and supply chains to protect network assets and user data. Exploiting vulnerabilities in these areas can lead to severe attacks, jeopardizing the overall network infrastructure.
The5G security landscape is multifaceted, encompassing challenges such as data privacy, integrity, authentication, and availability. Traditional security measures struggle to address the sophisticated and dynamic threats that characterize the 5G ecosystem. This has driven the exploration of advanced techniques to enhance network security. One promising solution is generative AI, which leverages machine learning models to simulate attack scenarios and generate insights to mitigate risks effectively.
As global reliance on 5G connectivity grows, ensuring the resilience and security of these networks is paramount. Generative AI offers a cutting-edge approach to tackling the evolving threat landscape, by enabling proactive threat detection and mitigation. This paper highlights the need for continued innovation in this domain, aiming to develop robust strategies to secure the future of 5G technology.
Why is security so paramount in 5G network?
The transformative capabilities of 5G networks—unparalleled speed, massive device integration, and ultra-reliable low- latency communication—have made them essential to modern industries. However, this technological leap has also introduced significant security risks that must be proactively addressed. Here are the primary reasons security is critical for 5G networks:
Figure 1: Attack surface of 5G
Figure 2: Security Threat in Critical infra
The figure below outlines Cyient's comprehensive 5G security solution powered by Generative AI. The solution leverages advanced algorithms and machine learning techniques to address critical aspects of 5G network security, including data processing, threat prediction, and automated response mechanisms.
Figure 3: GenAI based 5G Security solution
Key Solution Components:
Generative AI plays a pivotal role in identifying anomalies within massive datasets, a critical aspect of detecting security breaches in 5G networks. Key features include:
Generative AI-based machine learning models analyze historical data to predict potential threats and cyber-attacks. Highlights include:
Generative AI enables real-time, automated responses to detected threats, ensuring minimal downtime and rapid mitigation. Key capabilities include:
In addition to Generative AI-powered threat prediction, Cyient provides a suite of comprehensive security services tailored to telco networks:
Vulnerability Assessment and Penetration Testing (VAPT) – Detects vulnerabilities early using a structured framework. The framework ensures the identification of exposed risks and mitigates them effectively.
Figure 4: VAPT Framework
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Figure 5: Cyient’s intelligent SOC (iSOC) Approach
Figure 6: DevSecOps Security approach
Mukesh Bansal is Data and Technology leader for the communication industry at Cyient (EMEA). He advises customers on digital transformation, tools rationalization, OSS transformation, automation to reduce complexity, enhancing efficiency and realizing the business benefits using the GenAI and other latest technology and best practices.
Prachi Bhatnagar is a medical writer (Regulatory Affairs) specializing in Pharmaceuticals Clinical Affairs and Medical Writing, with over three years of hands-on experience in the industry. She has successfully supported multiple drug submissions for U.S. FDA, showcasing her in-depth understanding of regulatory requirements and submission processes.
Prachi has also conducted thorough medical reviews on Veeva Promo-Mats, ensuring compliance with the ABPI and EFPIA Codes of Practice. She has authored a range of critical regulatory documents, including Clinical and Non- Clinical overviews.
She is skilled in developing and implementing comprehensive regulatory strategies by conducting feasibility analysis, defining regulatory requirements, and efficiently coordinating with cross-functional teams. Her dedication to regulatory excellence and global compliance has made her a key contributor towards successful market entry for various pharmaceutical products.
She has also been a key contributor towards placing personal grooming product which involved thorough knowledge of chemicals consumer goods regulations across globally which comprises of Europe, U.S., APAC region.
Upon receipt of a De Novo request, the FDA will conduct an acceptance review. The acceptance review is an administrative review to assess the completeness of the application and whether it meets the minimum threshold of acceptability. If any of the acceptance elements are not included, a justification has to be provided for the omission.
To aid in the acceptance review, it is recommended to submit an Acceptance Checklist as per the guidance document with the De Novo request that identifies the location of supporting information for each checklist element.
The De Novo request will not be accepted and will receive a Refuse to Accept (RTA) designation if one or more of the elements noted as RTA items in the Acceptance Checklist are not present and no explanation is provided for the omission(s). However, during the RTA review, the FDA staff has the discretion to determine whether the missing checklist elements are needed to ensure the De Novo request is administratively complete to allow the De Novo request to be accepted.
Within 15 calendar days of the Document Control Center receiving the De Novo request, the FDA will notify the requester electronically of the acceptance review result as one of the following:
Once the De Novo request is accepted for substantive review, the FDA conducts a classification review of legally marketed device types and analyzes whether an existing legally marketed device of the same type exists. This information is used to confirm that the device is eligible for De Novo classification.
During the substantive review of a De Novo request, the FDA may identify deficiencies that can be adequately addressed through interactive review and not require a formal request for additional information.
If the issues and deficiencies cannot be addressed through interactive review, an Additional Information letter will be sent to the requester. If an Additional Information letter is sent, then the De Novo request will be placed on hold. The requester has 180 calendar days from the date of the Additional Information letter to submit a complete response to each item in the Additional Information letter.
Note: The response must be sent to the DCC within 180 calendar days of the date of the Additional Information letter. No extensions beyond 180 days are granted. If the FDA does not receive a complete response to all deficiencies in the Additional Information letter within 180 days of the date of the letter, the request will be considered withdrawn and deleted from the FDA's review system. If the De Novo request is deleted, the De Novo requester will need to submit a new request to pursue the FDA's marketing authorization for that device.
The requester must submit their response to an Additional Information letter in electronic format (eCopy), to the DCC of the appropriate center. The response should—
The final step is the De Novo request decision. Under MDUFA IV, the FDA's goal is to decide about a De Novo request in 150 review days. Review days are calculated as the number of calendar days between the date the De Novo request was received by the FDA and the date of the FDA's decision, excluding the days a request was on hold for an Additional Information request.
Cyient offers a one-stop solution, CyARC–Accelerated Regulatory Platform, for helping medical device companies to ensure regulatory compliance. Empowered by Quality Assurance and Regulatory Affairs (QARA) CoE, Cyient has certified professionals across all the functions who have the required skillsets and expertise to support medical device companies throughout the life-cycle of their medical devices.
Abhishek Kumar is an SME in Medical Device Regulatory Affairs, Quality Assurance, and Clinical Affairs with over 13 years of experience. He has led the EU MDR-2017/745 sustenance program, identifying business opportunities for sales teams, and managed the engagement program for a US-based medical device company. He has supported the gap assessment, remediation, and submission of 45+ Technical Documentations as per EU MDR, and created 40+ CERs for Class I, II, and III medical devices according to MEDDEV 2.7.1 Rev-4. Additionally, Abhishek has developed proposals for global markets, including Europe, US, ASEAN, China, Taiwan, and Japan, and prepared and implemented regulatory plans for NPD in 90+ countries by analyzing feasibility, defining requirements, and coordinating cross-functional teams.
